Label: DENTEK INSTANT PAIN RELIEF MAXIMUM STRENGTH- benzocaine liquid
Contains inactivated NDC Code(s)
NDC Code(s): 60630-077-01, 60630-077-02
- Packager: DenTek Oral Care. Inc.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not final
DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
Updated November 4, 2013
If you are a consumer or patient please visit this version.
Outer carton labeling
Allergy alert: do not use this product if you have a history of allergy to local anesthetics such as procaine, butacaine, benzocaine or other "caine" anesthetics.
When using this product • avoid contact with the eyes • do not exceed recommended dosage • do not use for more than 7 days unless directe
Stop use and ask a dentist or doctor if • swelling, rash or fever develops • irritation, pain or redness persists or worsens • symptoms do not improve in 7 days
Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.
Directions • dip applicator into liquid
Adults and children 2 years of age and older Apply a small amount of product to the affected area. Use up to 4 times daily or as directed by a dentist or doctor.
Other information • do not use if safety seal on carton is broken • this preparation is intended for use in cases of toothache, only as a temporary expedient until a dentist can be consulted • do not use continuously
Questions or comments? Call us 1-800-952-5080 M-F 8am - 5pm EST of visit our website www.dentek.com
- inner vial label
INGREDIENTS AND APPEARANCE
DENTEK INSTANT PAIN RELIEF MAXIMUM STRENGTH
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:60630-077 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength BENZOCAINE (UNII: U3RSY48JW5) (BENZOCAINE - UNII:U3RSY48JW5) BENZOCAINE 200 mg in 1 mL Inactive Ingredients Ingredient Name Strength POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ) SUCRALOSE (UNII: 96K6UQ3ZD4) Product Characteristics Color yellow (colorless to light yellow liquid) Score Shape Size Flavor PEPPERMINT, SPEARMINT Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:60630-077-02 1 in 1 CARTON 1 NDC:60630-077-01 3.7 mL in 1 VIAL, GLASS Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part356 02/01/2014 Labeler - DenTek Oral Care. Inc. (153818646) Registrant - DenTek Oral Care, Inc. (153818646)